Montelukast in asthmatic patients 6 years 14 years old with an FEV1>75%

Objectives: Montelukast is a potent leukotriene receptor antagonist effective for treating asthma symptoms in adult and pediatric patients. The purpose of this analysis was to assess the clinical efficacy of montelukast, a potent leukotriene-receptor antagonist, in a subgroup analysis of patients aged 6 years-14 years with milder asthma, defined as a percentage predicted forced expiratory volume in 1 s (FEV1) > 75% using data from a clinical trial of pediatric patients with a broad range of asthma severities. Research design and methods: The original previously published clinical trial was an 8-week multi-center, randomized, double-blind, parallel-group study conducted in 47 centers in the United States and Canada. The study compared the efficacy of once daily montelukast 5 mg to placebo in patients 6 years-14 years old with persistent asthma and an FEV1 ranging from 50% to 85% of predicted. A total of 87 patients in the montelukast group and 51 patients in the placebo group were selected from the original cohort of 336 patients based on percentage predicted FEV1 of > 75%. The primary endpoint was percentage change in FEV1 from baseline compared with placebo over 8 weeks of active treatment. Results: Montelukast significantly improved the primary endpoint of percentage change in FEV1 compared with placebo (p = 0.005). Other efficacy endpoints were significantly improved on montelukast similar to efficacy in the original study. Conclusion: Montelukast significantly improved FEV1, clinic measured peak expiratory flow (PEF), reduced nocturnal awakenings, and improved quality of life in children with milder persistent asthma defined as an FEV1 > 75% of predicted.